Engineered immune cells take on Hard-to-Treat lymphoma
NCT ID NCT06420089
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new treatment called Senza5 CART5 for people with a type of T cell lymphoma that has come back or not responded to standard therapy. The treatment uses the patient's own immune cells, modified to better target and attack cancer cells. The main goal is to find the safest and most effective dose, while monitoring side effects and initial signs of tumor shrinkage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically or cytologically confirmed relapsed or refractory (r/r) CD5-positive nodal peripheral T-cell lymphoma (such as peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), nodal T-cell lymphomas with T-follicular helper (TFH) phenotype, including follicular T cell lymphoma, angioimmunoblastic lymphoma, or anaplastic large cell lymphoma) or other non-leukemic CD5+ aggressive mature T cell lymphomas (such as enteropathy-associated T cell lymphoma, monomorphic epitheliotropic intestinal T cell lymphoma, transformed mycosis fungoides, primary cutaneous aggressive epidermotropic CD8+ cytotoxic T-cell lymphoma, primary cutaneous insert gamma delta symbols lymphoma, or subcutaneous panniculitis like T cell lymphoma). 2. ≥50% expression of CD5 on flow cytometry or IHC on malignant cells on the most recent biopsy 3. Must have received at least one line of prior systemic therapy for their lymphoma; participants with anaplastic large cell lymphoma (ALCL) must have received prior brentuximab unless there was a contraindication to brentuximab. 4. Evaluable disease defined by at least one lesion that can be measured in least 1 dimension and measures at least 1.5 cm in its longest dimension by CT or PET scan, or bone/bone marrow involvement, or skin involvement. 5. No circulating CD5+ malignant cells identified by peripheral blood flow cytometry must be present. Exclusion Criteria: 1. Pregnant or lactating (nursing) women. 2. HIV infection. 3. Concurrent use of systemic steroids or immunosuppressant medications. 4. Any uncontrolled active medical disorder that would preclude participation as outlined. 5. History of immunodeficiency. 6. History of prior chimeric antigen receptor therapy (CAR T), autologous or syngeneic HCT \<100 days from transplant at the time of cell infusion or previous allo-HCT. 7. Active and/or systemic inflammatory or autoimmune diseases. 8. Signs or symptoms indicative of active CNS involvement. 9. Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to lymphoma or previous lymphoma treatment. 10. Clinically apparent arrhythmia, or arrhythmias that are not stable on medical management 11. Current participation in or prior participation in a study of an investigational agent or using an investigational device within 2 weeks of the first dose of treatment. 12. Prior monoclonal antibody therapy within 4 weeks prior to study Day 1 13. Prior use of alemtuzumab 14. Prior chemotherapy targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 15. Uncontrolled active infection requiring systemic therapy. 16. Circulating CD5+ malignant cells identified by peripheral blood flow cytometry present. 17. Active and/or systemic inflammatory or autoimmune diseases.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Columbia University Irving Medical Center
RECRUITINGNew York, New York, 10032, United States
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University of Pennsylvania - Abramson Caner Center
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Engineered immune cells target CD5 in Hard-to-Treat T-Cell lymphomas
- Engineered donor cells take aim at tough blood cancers in early trial
- Experimental CAR T-Cell therapy targets tough lymphoma
- Engineered cells take on hard-to-treat blood cancers in early trial
- Supercharged cord blood cells take on resistant blood cancers
- Cord blood cells engineered to fight Hard-to-Treat blood cancers